NEW PRESENTATION: TT21C NON-ANIMAL TOXICITY TESTING STRATEGY: TEN YEARS OF INSPIRATION TO APPLICATION TO NEXT GENERATION RISK ASSESSMENTS (NGRA)

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What is a Next Generation Risk Assessment (NGRA)? Ten years ago the National Research Council was asked by the U.S. Environmental Protection Agency to review the state of the science and create a far-reaching vision for the future of toxicity testing. Today, through the application of these novel approaches, a NGRA becomes an exposure-led risk assessment solution to biological pathway-indicated hazard concerns. Indeed, since the publication of the inspirational book `Toxicity Testing in the 21st Century (TT21C): a Vision and a Strategy┬┐ many scientists from various disciplines, have been working to realise the challenge of how new technological advances in molecular biology and computational modelling can be brought together to make safety decisions without the need for animal testing. Through extensive collaboration and evaluation of case study chemicals, we have arrived at a tiered approach that can adapt and improve. In silico-first approaches with informatics data-mining are initially used to identify pathways of concern and to formulate hypotheses for testing. Next, lead molecular initiating events (MIEs) and on/off-target pathways are evaluated with respect to relevant exposures through in vitro experimental data generation (transcriptomics, screening panels, high content imaging) teamed with computational modelling. Potentially, a final tier employing organotypic human cell models or more complex toxicokinetic/toxicodynamic computational models may be utilised to provide additional confidence in predictive safety decision making.

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